MICROPERIMETER MP-3

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 6. 2016 Nidek Co., Ltd. % Enrico Bisson Regulatory Affairs Manager Nidek Technologies Srl Via Dell' Artigianato, 6/a Albignasego (Padova), 35020 IT Re: K152729 Trade/Device Name: Microperimeter MP-3 Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI, HPT Dated: April 19, 2016 Received: May 3, 2016 Dear Mr. Bisson: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Denise L. Hampton -S for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) Device Name MP-3 MICROPERIMETER Indications for Use (Describe) MP-3 MICROPERIMETER is indicated for use as: Color retinography Fixation examiner Fundus-related microperimetry Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED, FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect. of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of a sourser any information unless it displays a currently valid OMB number." FORM FDA 3881 (1/14) 14119 14:33:30 Page 1 of 1 PSC Publishing Services (301) 443-6740 E {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for NIDEK, a company that specializes in eye care products. The logo features a stylized eye in a blue box, with the word "NIDEK" printed in bold, sans-serif font below the eye. The eye is white with a blue outline, and the pupil is represented by a white circle. The overall design is simple and modern, conveying a sense of trust and expertise in the field of ophthalmology. Image /page/3/Picture/1 description: The image shows the text "NIDEK CO., LTD." in bold, followed by the address "34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan" in a smaller font size. The text appears to be a company name and address. The text is left-aligned and the background is a light color. TEL +81-533-67-6611 FAX +81-533-67-6610 URL http://www.nidek.co.jp This summary of the 510(k) premarket notification for the Microperimeter MP-3is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92. # 510(k) Notification # GENERAL INFORMATION # Applicant: NIDEK CO., LTD. 34-14 Maehama, Hiroishi Gamagori, Aichi, 443-0038 Japan | Contact Person: | Yoneji Mizuno | | | | | | |-------------------------|--------------------------------------------------|--|--|--|--|--| | Contact Title: | Corporate Officer and Senior Manager, Regulatory | | | | | | | | Affairs Department | | | | | | | Contact Phone Number: | +81-533-67-8901 | | | | | | | Contact Fax Number: | +81-533-67-6628 | | | | | | | E-mail: | yoneji_mizuno@nidek.co.jp. | | | | | | | | | | | | | | | Official Correspondent: | Enrico Bisson | | | | | | | Contact Title: | Manager, Regulatory Affairs Department | | | | | | | | Nidek Technologies Srl | | | | | | | | Via dell'Artigianato, 6/A, | | | | | | | | 35020 Albignasego (Padova) , Italy | | | | | | | Contact Phone Number: | +39-049 8629200 | | | | | | | Contact Fax Number: | +39-049 8626824 | | | | | | | E-mail: | enricobisson@nidektechnologies.it | | | | | | | | | | | | | | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for NIDEK. The logo consists of a blue eye symbol above the word "NIDEK" in blue, block letters. To the right of the logo are the words "34-14, Mae" and "Manufacturer" in a smaller, sans-serif font. | TEL | +81-533-67-6611 | |-----|-----------------| |-----|-----------------| FAX +81-533-67-6610 http://www.nidek.co.jp http://www.nidek.com Date Prepared: September 4, 2015 Classification: 21 CFR§ 886.1120, Class II - 21 CFR§ 886.1605 , Class I # Classification name: Camera, Ophthalmic, AC-Powered Perimeter, Automatic, AC-Powered # Product Code: HKI. HPT Trade Name: Microperimeter MP-3 Generic/Common Name: MICROPERIMETER Predicate Device MP-1 MICROPERIMETER (K023719) Nidek Technologies Srl # Indications for use The Microperimeter MP-3is indicated for use as: Color retinography Fixation examiner Fundus-related microperimetry # Product Description The Microperimeter MP-3performs the following basic functions: Color retinography Fixation examiner Fundus-related microperimetry {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for NIDEK, a company that specializes in eye care products. The logo features a stylized eye in a blue square. The word "NIDEK" is printed in bold, sans-serif font below the eye. The logo is simple and modern, and the blue color is associated with trust and reliability. 34-14, Maehama, Hiroishi-cho, Gamagori, Aichi 443-0038, Japan Manufacturers, Exporters & Importers of Ophthalmic Instruments, and Opto-Electronics Instrumen TEL +81-533-67-6611 FAX +81-533-67-6610 URL http://www.nidek.co.jp http://www.nidek.com #### Color retinography This function allows a 45° image of the efthe eye fundus to be acquired without the need for a mydriatic agent. Auto alignment is performed while observing on the LCD, the front of the patient's eve illuminated by the eve front illumination LED (infrared light). After the alignment is roughly complete, the mode automatically changes to the fundus observation mode. The fundus of the patient's eye is illuminated by the fundus illumination LED (infrared light). After alignment and focusing are automatically performed on the fundus, white light from the xenon flash lamp is emitted on the fundus. The light reflected from the fundus is captured by the built-in color CCD camera for fundus image capture. #### Fixation examiner This function allows recording of the patient's fixation position changes in time and plotting of them onto a stable retinal image, acquired at the beginning of the exam. It is therefore an accurate survey of the stability of fixation itself. # Fundus-related microperimetry This function allows a visual sensitivity mapping that can be displayed using static perimetry principle. Stimuli and a fixation target are displayed by the built-in LCD projector. While focusing on the fixation target, the patient presses the response button to indicate that they saw a stimulus projected at the location and light intensity specified by the internal measurement program or the operator. The patient's response signals are computed by the device and measurement results are displayed on the LCD. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for NIDEK. The logo consists of a blue square with a stylized eye inside, and the word "NIDEK" printed below the eye. To the right of the logo is the word "NIDEK" in large, bold letters. Below the word "NIDEK" is the address "34-14, Maehama" and the text "Manufacturers, Exporters". Gamagori, Aichi 443-0038, Japan ers of Ophthalmic Instruments, and Opto-Electronics Instruments ### Substantial Equivalence The Microperimeter MP-3is substantially equivalent to the predicate device with regard to design, function, technological characteristics, intended use and performance characteristics. The differences between the proposed and predicate device and justifications as to why these differences do not raise safety or efficacy concerns are as follows. #### Differences in Color retinography The subject device may perform alignment and focusing automatically, while the predicate device performs the same operation only manually. #### Differences in Fixation examiner The subject device may perform alignment and focusing automatically, while the predicate device performs the same operation only manually. The exam is performed in the same way, but the subject device has improved the result display. #### Differences in Fundus-related microperimetry The subject device may perform alignment and focusing automatically, while the predicate device performs the same operation only manually. The background luminance can be set at 31.4 asb or 4 asb, while the predicate device allowed only 4 asb. The maximum stimulus luminance is 10,031.4asb, while the predicate device allows only 404asb. These larger ranges don't raise any safety issue.Compliances with both the light hazard recognized standards ISO 15004-1 and ISO 15004-2, and voluntary ISO 12866 standards are documented in Appendix 2.8 and 2.9. The design modifications outlined in this Special 510(k) premarket notification do not (1) affect the intended use or the indication for use or (2) alter the fundamental scientific technology of the device. The proposed Microperimeter MP-3shares the equivalent indications for use, the same technological characteristics and the same principle of operation as the predicate devices. Therefore, based on the similarities between the devices, the {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for NIDEK. The logo features a stylized eye graphic in blue, with the word "NIDEK" printed below it in a sans-serif font. To the right of the logo are the numbers "34-14" and the word "Manufacturing". i-cho, Gamagori, Aichi 443-0038, Japan Importers of Ophthalmic Instruments, and Opto-Electronics Instruments proposedMicroperimeter MP-3 is substantially equivalent to MP-1MICRO PERIMETER (K 023719). # Testing in Support of Substantial Equivalence Determination We have verified and validated that the Microperimeter MP-3meets its functional specifications and performance requirements, and complies with applicable international standards (IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2,ISO 12866, ISO 10940). As mentioned, all necessary bench testing was conducted on the modifications, the addition of the proposed Microperimeter MP-3, to support a determination of substantial equivalence to the predicate device. # Summary of Safety and Effectiveness All the necessary safety tests were performed and documented. The results demonstrate that the subject device complies with applicable international standards (IEC 60601-1, IEC 60601-1-2, ISO 15004-1, ISO 15004-2,ISO 12866, ISO 10940) and it is safe as the predicate device. All the necessary performance tests in support of substantial equivalence determination were conducted. The tests demonstrate that the subject device is effective and performs as well as the predicate device. The minor differences between the devices do not raise any new issues of safety or efficacy. Thus the proposed Microperimeter MP-3 is substantially equivalent to the predicate device.